Cascadian Therapeutics is a clinical-stage biopharmaceutical company specializing in developing innovative therapeutic product candidates for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is tucatinib (ONT-380), an orally active and selective small molecule HER2 inhibitor. We are headquartered in Seattle, Washington. For more information, visit www.cascadianrx.com.
The Principal Statistical Programmer/Analyst provides programming expertise in support of the clinical development process. This includes developing SAS programs to monitor, analyze, and report clinical trial data and managing programming activities and deliverables for contract programmers and external vendors. Acts as a liaison between data management, biostatistics, and clinical operations as needed.
Key Job Responsibilities:
- Develops SAS programs to analyze and report clinical trial data for CSRs, annual reports, regulatory submissions and publications.
- Manages programming activities and deliverables for contract SAS programmers and external vendors.
- Develops and maintains standard SAS macros, templates, and programming standards for biometrics department.
- Develops and maintains SDTM and ADaM data set specifications for clinical studies
- Programs SDTM and ADaM data sets for clinical studies.
- Participates in the review of statistical analysis plans, study CRFs, edit check specifications, and database design specifications.
- Programs SAS edit checks to assist data management's data cleaning activities.
- Develops and maintains the SAS environment and license for the biometrics department.
- Assists in the preparation of NDAs/BLAs.
- Assists in the develop and writing of departmental SOPs.
- Performs other responsibilities as assigned.
Education / Experience / Professional Requirements:
- Bachelor's degree in a computer science, mathematics, statistics, or health-related field (or equivalent).
- Ten or more years of relevant experience, including experience in the pharmaceutical or life sciences industry.
- Knowledge of FDA regulatory requirements and ICH/GCP guidelines preferred.
- Knowledge of CDISC standards.
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines, with background in oncology preferred.
- Excellent knowledge of SAS programming and applications in the pharmaceuticals industry and clinical trial data setting is required.
- Demonstrated understanding of and experience with clinical trial data and data manipulations, analysis and reporting of analysis results.
- Excellent application development skills required.
- Excellent overall computer proficiency required (PC-Windows preferred) and proficiency in Microsoft Word, Excel, PowerPoint, and Sharepoint.
- Clear and concise verbal and written communication skills.
- Detail oriented with excellent analytical and problem-solving skills.
- Ability to prioritize and handle multiple tasks and projects simultaneously in a fast-paced environment.
- Ability to work independently and in a highly collaborative team environment.
- Dedication to quality and reliability in all work tasks.
- Self-motivated, eagerness to grow professionally and commitment to self-development.
Cascadian Therapeutics offers a comprehensive and highly competitive benefits package including medical, dental, vision care, life insurance, short and long term disability, stock options, ESPP, a matching traditional and ROTH 401(k) plan, and fully subsidized transit pass/parking.
If you are interested in working with our team in a collaborative and professional work environment, please Submit Resume ».
We are an Equal Opportunity Employer